BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOLUMAT MC AGILIA US

    MDR report key: 20931323 · Received December 13, 2024

    Report

    Report Number
    3000240707-2024-00467
    Event Type
    Death
    Date Received
    December 13, 2024
    Date of Event
    November 22, 2024
    Report Date
    January 29, 2025
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    UDI-DI
    04086000851794
    PMA / PMN Number
    K121613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED AND NOTHING WAS FOUND RELATED TO THE REPORTED EVENT. DEVICE LOG HISTORY WAS NOT PROVIDED THEREFORE NO REVIEW COULD BE PERFORMED. THE REPORTED DEVICE WAS NOT RETURNED TO (B)(4) FOR INVESTIGATION. PROVIDED INFORMATION INDICATES THAT THE DEVICE IS LIKELY STILL IN USE AND NO REPAIRS WERE PERFORMED BY OUR LOCAL TEAM AS NO QUALITY CONTROL CHECK HAS BEEN REQUESTED BY THE CUSTOMER. ACCORDING TO PROVIDED INFORMATION, A NURSE MADE A MISTAKE WHEN SELECTING A DRUG BY PROGRAMMING NOREPINEPHRINE MCG/MIN INSTEAD OF NOREPINEPHRINE MCG/KG/MIN ON A PATIENT WEIGHING 106KG I.E. AN UNDERDOSE OF 106 LESS. THEREFORE, THIS COMPLAINT IS CONSIDERED AS A USE ERROR. IN FACT, THIS COMPLAINT WAS A CUSTOMER EXPECTATION TO SUGGEST A CHANGE IN THE HMI OF AGILIA. HOWEVER, CHANGING THIS INTERFACE IS ALSO UP TO CUSTOMER VIA DRUGLIB. THE PATIENT DIED A FEW DAYS LATER OF SCEPTIC SHOCK. ACCORDING TO PROVIDED INFORMATION, THIS UNDERDOSE WAS NOT THE CAUSE OF DEATH. THEREFORE, AN EVENT WAS CREATED AND THIS COMPLAIN IS RE-CLASSIFIED AS AN S-3 (MODERATE) INSTEAD OF S-5(CATASTROPHIC) SEVERITY. THIS COMPLAINT IS CONSIDERED AS: USE ERROR. THE TREND IS: NORMAL.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: (B)(6) HAD A TRAVELING NURSE RECENTLY SELECT MCG/MIN INADVERTENTLY WHEN MCG/KG/MIN WAS INTENDED TO BE SELECTED. SPECIFICALLY THE ORDER WAS FOR 0.03MCG/KG/MIN, BUT THE NURSE INITIALLY SELECTED THE DOSING OPTION OF MCG/MIN ON THE PUMP WHICH ULTIMATELY MEANT THE DOSE THE PATIENT RECEIVED WAS 106X LESS THAN WHAT THE ORIGINAL ORDER WAS INTENDED TO BE. THE PATIENT IN QUESTION WEIGHED 106KG. NO SAMPLE AVAILABLE NO LETTER REQUESTED EMAILED CUSTOMER ON 12/9/2024 TO DETERMINE IF PATIENT SUFFERED ANY ADVERSE EVENTS RELATED TO THE UNDERDOSE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER'S PHARMACIST " "PER EMAIL ON 12/10/2024 I MESSAGED ONE OF OUR EMERGENCY ROOM PROVIDERS AND HOSPITALIST TO GET THEIR TAKE ON IF THE PATIENT SUFFERED ANY ADVERSE EVENTS RELATED TO THE UNDERDOSE AND THEY WAS THEIR RESPONSE: "HARD TO SAY. I MEAN SHE ULTIMATELY PASSED FROM SEPTIC SHOCK THE NEXT DAY AND THAT IS WHAT WE WERE TREATING, BUT SHE WAS BEING TREATED WITH OTHER PRESSORS UNTIL THE ISSUE WAS RESOLVED." OVERALL THE NOREPINEPHRINE APPEARED TO NOT BE EFFECTIVE, AS IT WAS ACTUALLY UNDERDOSED, AND OTHER PRESSERS WERE USED INSTEAD WHICH IS APPROPRIATE COURSE OF TREATMENT IF FOR SOME REASON NOREPINEPHRINE WERE NOT EFFECTIVE AT THE TYPICAL DOSE." " REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EFFECTS WERE REPORTED. MORE INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805470 VOLUMAT MC AGILIA US INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. Z021135 04086000851794

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death